Traditional Chinese medicine composition for relieving or treating functional constipation, gel ointment and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine composition for relieving or treating functional constipation, a gel ointment and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine composition is prepared from the following raw materials: radix paeoniae alba, pericarpium citri reticulatae, radix rehmanniae, angelica sinensis body, liquorice, almond, fistular onion stalk and aloe concentrated juice. The invention further provides a gel ointment containing the traditional Chinese medicine composition, the gel ointment comprises the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials, for example, carbomer is used as a gel matrix, chlorhexidine acetate is used as a preservative, and NaOH is used as a pH regulator. The preparation method comprises the following steps: preparing the traditional Chinese medicine extract and the scallion juice; dispersing carbomer into the aloe concentrated juice to form initial gel; adding a NaOH solution to adjust the pH value to 5.5-6.5; and adding the traditional Chinese medicine extract, the preservative and the scallion juice into the gel, and uniformly mixing. The traditional Chinese medicine composition disclosed by the invention has a good bowel relaxing effect.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for relieving or treating functional constipation, a gel ointment and a preparation method thereof. BACKGROUND

[0002] Constipation is a common digestive system disease, mainly manifested as reduced defecation frequency, difficulty in defecation, and dry and hard stool. With the change of modern lifestyle, the incidence of constipation is increasing year by year, and has become an important health problem affecting people's quality of life. At present, the methods for treating constipation in clinic mainly include drug treatment, diet conditioning and lifestyle intervention, among which drug treatment is one of the most commonly used methods.

[0003] In the theory of traditional Chinese medicine, constipation is mainly caused by insufficient intestinal fluid, unsmooth qi movement, and intestinal conduction dysfunction. Traditional Chinese medicine treatment of constipation has the characteristics of overall regulation and treatment of both symptoms and root causes, and is widely used in clinic. Existing traditional Chinese medicine laxative preparations mainly include oral preparations and external use preparations. Oral preparations such as CN108524897A disclose a drug for treating functional constipation of qi-yin deficiency type, which comprises many traditional Chinese medicine components such as fried licorice, raw rehmannia, ophiopogon, angelica, red peony root, white peony root, etc., and treats constipation by tonifying qi and nourishing yin, tonifying liver and kidney, and filling essence and blood. CN109381454B discloses a laxative capsule containing active ingredients such as aloe glycoside, hesperidin, and magnolol, and the raw materials are composed of aloe, citrus fruit, ginger magnolia, raw rehmannia, white peony root, angelica, and radix codonopsis. CN106038820A discloses a food-drug homologous traditional Chinese medicine composition for improving functional constipation, which is composed of hemp seeds, white peony root, citrus fruit, magnolia flower, apricot kernel, angelica, etc., and has the effects of laxative, yin-nourishing and dryness-moistening, and liver and kidney tonifying.

[0004] External use laxative preparations mainly include Kaiselu, suppositories, gels, etc. CN118340840A discloses a composition with laxative function, which is prepared from traditional Chinese medicine raw materials such as ginseng, ophiopogon, cassia twig, cassia bark, and astragalus, and treats constipation of qi deficiency through multiple mechanisms such as tonifying heart yang, tonifying lung qi deficiency, and tonifying spleen qi deficiency. CN112546191A discloses a laxative composition comprising rhubarb, magnolia, aloe, citrus fruit, senna leaf, etc., and has the effects of inducing heat downward and laxative.

[0005] However, the existing intestinal lubricating laxative products still have some problems and deficiencies. First, many traditional laxative products such as purgative preparations are prone to cause abdominal distension, diarrhea and other irritating side effects, and long-term use may lead to intestinal peristalsis function dependence. Second, the Kaiselu product has the problems of drug loss and unstable effect during use, which affects the treatment effect. Third, the traditional external use products have poor use experience, such as not easy to fit the rectal mucosa, easy to lose, strong anal irritation, inconvenient to apply, easy to adhere to clothes, etc., which reduces the patient's compliance. In addition, the stability and safety of the existing products also need to be improved, especially the long-term use safety problem has not been fully solved.

[0006] Therefore, it is of great significance to develop a traditional Chinese medicine composition and its preparation with good intestinal lubricating laxative effect, convenient use, small side effect and good stability for improving constipation symptoms and improving the quality of life of patients. SUMMARY

[0007] In view of the problems of the prior art, the present application provides a traditional Chinese medicine composition for relieving or treating functional constipation in children, a gel ointment and a preparation method thereof.

[0008] The present application is realized by the following technical solutions: Firstly, the present application provides a traditional Chinese medicine composition for relieving or treating functional constipation, which is made of the following raw materials by weight: white peony 50-56 parts, dried tangerine or orange peel 20-40 parts, raw rehmannia 30-37 parts, angelica stem 30-41 parts, licorice 15-19 parts, almond 3-6 parts, green onion 10-12 parts, and aloe vera concentrate 50-70 parts.

[0009] Preferably, the aloe vera concentrate is aloe vera leaf juice concentrate with a purity of ≥99%.

[0010] Preferably, the traditional Chinese medicine composition is made of the following raw materials by weight: white peony 55.95 parts, dried tangerine or orange peel 37.3 parts, raw rehmannia 37.3 parts, angelica stem 37.3 parts, licorice 18.65 parts, almond 6 parts, green onion 12 parts, and aloe vera concentrate 50 parts.

[0011] Traditional Chinese medicine believes that "body fluids and blood share the same origin." Blood deficiency leads to insufficient body fluids, resulting in dry intestines and constipation. This formula uses white peony root and angelica root as the chief herbs, aiming to nourish yin and blood, increasing fluid production at its source to provide the material basis for smooth bowel movements. Angelica root is particularly effective at nourishing blood, and its oily properties also moisten the intestines. Aloe vera and rehmannia root are the assistant herbs. Aloe vera is cold in nature and has a strong laxative effect, acting directly on the intestines to expel accumulated waste. Combined with the blood-nourishing white peony root and angelica root, it forms a "combination of tonification and purgation," ensuring a rapid laxative effect without harming the body's vital energy, avoiding the drawbacks of pure tonification leading to stagnation or pure purgation leading to damage. Rehmannia root assists the chief herbs in nourishing yin and blood; its cold nature also clears away any internal heat that may be caused by constipation, further increasing fluid production and moistening the intestines. Tangerine peel, apricot kernel, and scallion are the adjuvant herbs. Tangerine peel is good at regulating qi; when qi flows smoothly, body fluids are distributed, and the intestines are unblocked. Meanwhile, its qi-regulating effect can prevent the blood-nourishing and yin-tonifying principal herbs from being too greasy and cloying, thus hindering the stomach. Almonds are moist and oily, able to moisten dryness and promote bowel movements. Furthermore, they belong to the lung meridian and can disperse and descend lung qi. According to the traditional Chinese medicine theory that "when lung qi descends, the large intestine is unobstructed," this promotes the transmission function of the lower jiao (intestines) by opening and dispersing lung qi in the upper jiao. Scallion whites are pungent and warm, able to promote yang qi. Adding a small amount of warming scallion whites to a yin-nourishing and moistening formula can achieve the effect of "seeking yin within yang," stimulating and promoting the distribution of yin fluids and intestinal peristalsis by warming and dispersing yang qi, thus preventing the entire formula from being too cold and stagnant. Licorice in this formula mainly plays a harmonizing role, moderating the drastic purgative nature of aloe vera, coordinating the cold and warm properties of the herbs, protecting the qi of the spleen and stomach, so that the entire formula works synergistically without being excessive. In summary, the composition addresses the root cause by using white peony root, angelica root, and rehmannia root to nourish yin and blood; aloe vera to purge and relieve constipation; tangerine peel and apricot kernel to regulate qi and assist in bowel movement; scallion to invigorate yang qi and aid digestion; and finally, licorice root to harmonize the effects of all the herbs. This formula treats both the root cause and the symptoms, relieving constipation without harming the body's vital energy. It is particularly suitable for functional constipation caused by physical weakness and insufficient yin and blood (especially in children, the elderly, and postpartum women).

[0012] Secondly, the present invention provides a gel ointment for relieving or treating functional constipation, which comprises the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0013] Preferably, the pharmaceutically acceptable excipients include gel matrix, preservatives, and pH adjusters.

[0014] More preferably, the gel matrix is ​​carbomer, the preservative is chlorhexidine acetate, and the pH adjuster is NaOH.

[0015] More preferably, based on the total weight of the gel ointment, the amount of carbomer is 0.3% to 0.8%, preferably 0.5%, and the amount of chlorhexidine acetate is 0.01% to 0.05%, preferably 0.05%.

[0016] Finally, the present invention also provides a method for preparing the above-mentioned gel ointment, comprising the following steps: (1) Chinese medicine extract and onion juice preparation: according to the proportion, white peony root, dried tangerine or orange peel, raw rehmannia, angelica stem, licorice, apricot kernel are combined and extracted with water, the extract is concentrated to obtain Chinese medicine extract, and onion white is chopped and juiced to obtain onion juice; (2) Disperse the gel matrix in the aloe concentrated juice to swell and form a preliminary gel; (3) Add NaOH solution to the preliminary gel obtained in step (2) to adjust the pH to 5.5-6.5, and stir until it is completely gelled; (4) Add the Chinese medicine extract obtained in step (1) to the gel obtained in step (3) and stir to mix evenly, then add preservatives and onion juice, and stir to mix evenly.

[0017] Preferably, in step 1, the mass-volume ratio of water to medicinal materials is 1:5-10, unit g / ml; the extraction method is to soak for 30-60 minutes first, then decoct three times, the first time for 1.5 hours, the second time for 1 hour, and the third time for 0.5 hours, combine the filtrate and concentrate.

[0018] Preferably, the concentration is concentrated to 1.10-1.15 (60°C).

[0019] Preferably, in step (2), the gel matrix is carbomer 940; the swelling is 30-40 minutes under stirring speed of 150-200 r / min; in step (3), the NaOH solution is a solution of NaOH and water in a ratio of 1:4.

[0020] Preferably, in step (4), the stirring is mixing for 15-20 minutes at a stirring speed of 60-80 r / min.

[0021] Compared with the prior art, the present application has the following beneficial effects: 1. The Chinese medicine composition in the present application uses white peony root to nourish blood and ying, dried tangerine or orange peel to regulate qi, raw rehmannia to nourish yin, apricot kernel to moisten the intestines, and licorice to harmonize all medicines, supplemented by onion white to unblock yang, and aloe concentrated juice to clear heat and moisten the intestines. The combination of various drugs has a synergistic effect, and the effect is mild and accurate.

[0022] 2. In the gel ointment of the present application, the aloe concentrated juice is both a drug active ingredient and a solvent for the gel ointment. The Chinese medicine extract and the aloe active ingredient have a synergistic effect, which can stimulate the intestinal peristalsis mildly, promote the softening and excretion of feces, and use carbomer as the matrix to make the gel ointment, which has moderate gel viscosity and good air permeability, is not easy to lose from the rectal mucosa, reduces the anal irritation, and is convenient to apply and use, without the trouble of sticking to clothes. It is suitable for short-term relief of constipation symptoms and long-term regulation of intestinal function.

[0023] 3. Good user experience: The present invention uses carbomer as the matrix. By precisely controlling the pH value within the range of 5.5 - 6.5, the gel has moderate viscosity and good air permeability, can better adhere to the rectal mucosa without easy loss, significantly reduces the anal irritation, and is convenient to apply and use without the trouble of sticking to clothes, greatly improving the user experience of patients.

[0024] 4. High stability and safety: Through optimized formulation and process, the product has uniform texture and good stability, and there is no delamination or deterioration after high and low temperature cycling tests. Chlorhexidine acetate with a compliant dosage is added as a preservative to effectively inhibit the growth of microorganisms and ensure the safety and stability of the product during storage. Description of the Drawings

[0025] Figure 1 It is the finished product diagram of the gel plaster prepared in Examples 4 - 6. Detailed Embodiments

[0026] The present invention will be further described in detail below with reference to the drawings and examples, but it is not limited in any way. Any transformation or improvement made based on the teachings of the present invention falls within the protection scope of the present invention.

[0027] The processes, conditions, reagents, experimental methods, etc. for implementing the present invention, except for the specifically mentioned content below, are all common knowledge and well-known common sense in the art, and the present invention has no special limiting content. For the experimental methods without specific conditions indicated in each example, they are usually carried out under conventional conditions or according to the conditions recommended by the manufacturer.

[0028] Unless otherwise specified, the meanings of all professional terms and scientific terms used in this specification are the same as those generally understood by those skilled in the technical field to which the present invention belongs. But in case of conflict, the present specification containing the definitions shall prevail.

[0029] The following are the sources of the main raw materials in the examples: According to the Chinese Pharmacopoeia (2023 Edition), the Latin name of Paeonia lactiflora Pall. (White Peony Root) in the prescription is Paeoniae Albae Radix , and its source is the dried root of the herbaceous peony plant Paeonia lactiflora Pall., which is usually dug in summer and autumn. After washing, the head, tail and fine roots are removed, and then it is boiled in boiling water to remove the outer skin or peeled and then boiled again, and then dried; the Latin name of Pericarpium Citri Reticulatae (Dried Tangerine Peel) is Paeonia lactiflora Pall. , and its source is the dried ripe pericarp of the citrus plant Citrus reticulata Blanco and its cultivated varieties. The medicinal materials are divided into "Pericarpium Citri Reticulatae" and "Pericarpium Citri Reticulatae Viride". After picking the ripe fruits, the pericarp is peeled off and dried or dried at low temperature; the Latin name of Rehmannia glutinosa Libosch. (Dried Rehmannia Root) is Citri Reticulatae Pericarpium , and its source is the dried root of the plant Rehmannia glutinosa Libosch. of the family Scrophulariaceae Citrus reticulata Blanco Rehmanniae Radix Rehmannia glutinosa (Gaertn.) Libosch. ex Fisch. et Mey ​​The fresh or dried tuberous roots of Angelica sinensis, harvested in autumn after removing the rhizome, fibrous roots, and mud, are commonly known as "fresh Rehmannia root" when used fresh. Those that are slowly baked until about 80% dry and then formed into clumps are commonly known as "raw Rehmannia root." The Latin name for Angelica sinensis is... Angelicae Sinensis Radix The source is Angelica sinensis, a plant of the Apiaceae family. Angelica sinensis (Oliv.) Diels The dried roots of licorice are generally harvested in late autumn. After removing the fibrous roots and soil, and allowing some moisture to evaporate, they are bundled into small bunches and slowly dried using smoke over a shed. The Latin name for licorice is... Glycyrrhizae Radix et Rhizoma The source is licorice, a legume. Glycyrrhiza uralensis Fisch ., Licorice inflata Glycyrrhiza inflata Bat. Or licorice root Glycyrrhiza glabra L. The dried roots and rhizomes are harvested in spring and autumn, the fibrous roots are removed, and then they are dried in the sun; almonds (bitter almonds) have the Latin name... Armeniacae Semen Amarum, The source is the Rosaceae plant, Prunus armeniaca. Prunus armeniaca L. var. ansu Maxim Siberian apricot Prunus sibirica L. Northeast apricot Prunus mandshurica (Maxim.) Koehne Or apricot Prunus armeniaca L. The dried, mature seeds of scallion are harvested in summer from mature fruits. After removing the pulp and shell, the seeds are extracted and dried. The white part of the scallion is called scallion in Latin. Allii Fistulosi Bulbus The source is the lily family plant allium. Allium fistulosum L. The bulbs near the base can be harvested at any time. After harvesting, cut off the bulbs, wash them, and use them fresh. Aloe vera concentrate (aloe) has the Latin name... Aloe The source is Aloe barbadensis, a plant in the Liliaceae family. Aloe barbadensis Miller Cape Aloe Aloe ferox Miller It is a concentrated and dried product of the sap from the leaves of other closely related plants of the same genus. The leaves are cut before the plant flowers, and the sap that flows out is collected, concentrated, and dried.

[0030] Example 1 This embodiment provides a traditional Chinese medicine composition for relieving or treating functional constipation in children. The composition is made from the following raw materials in parts by weight: 55.95 parts of white peony root, 37.3 parts of dried tangerine peel, 37.3 parts of raw rehmannia root, 37.3 parts of angelica root, 18.65 parts of licorice root, 6 parts of apricot kernel, 12 parts of scallion, and 50 parts of concentrated aloe vera juice.

[0031] Example 2 This embodiment provides a traditional Chinese medicine composition for relieving or treating functional constipation in children. The composition is made from the following raw materials in parts by weight: 50.12 parts of white peony root, 40.5 parts of dried tangerine peel, 30.3 parts of raw rehmannia root, 30.4 parts of angelica root, 15.2 parts of licorice root, 3.4 parts of apricot kernel, 10.1 parts of scallion, and 60 parts of concentrated aloe vera juice.

[0032] Example 3 The present embodiment provides a traditional Chinese medicine composition for relieving or treating functional constipation in children, which is prepared from the following raw materials in parts by weight: Radix Paeoniae Alba 55.23 parts, Pericarpium Citri Reticulatae 20.3 parts, Radix Rehmanniae 35.4 parts, Radix Angelicae Sinensis 40.8 parts, Radix Glycyrrhizae 15.7 parts, Semen Armeniacae Amarum 3.1 parts, Allium fistulosum 10.3 parts, and aloe juice concentrate 70 parts.

[0033] Embodiment 4 The present embodiment provides a preparation method of a gel ointment for relieving or treating functional constipation, which comprises the following steps: (1) Traditional Chinese medicine extract and onion juice preparation: Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Radix Rehmanniae, Radix Angelicae Sinensis, Radix Glycyrrhizae, and Semen Armeniacae Amarum are combined and soaked in 10 times the amount of cold water for 45 minutes, and then decocted for three times: 1.5 hours for the first time, 1 hour for the second time, and 0.5 hours for the third time. The three decoction liquids are combined, filtered, and concentrated to a relative density of 1.15 (60°C) to obtain the extract. Allium fistulosum is chopped and juiced to obtain the onion juice.

[0034] (2) Under stirring (70 r / min), carbomer 940 (0.5% addition) is slowly added to the aloe juice concentrate, and the feeding time is about 12 minutes. After feeding, the stirring speed is increased to 180 r / min, and stirring is continued for 35 minutes until the system is a uniform viscous liquid without visible particles, and an initial gel is obtained.

[0035] (3) Keep stirring, and slowly add NaOH solution (1:4) to the initial gel, and monitor the pH value with a precision pH meter during the process to adjust the pH value of the system to 6.0. Continue stirring for 22 minutes until a transparent and uniform gel is formed.

[0036] (4) Reduce the stirring speed to 70 r / min, add the traditional Chinese medicine extract prepared in step (1), and stir for 18 minutes to make it uniformly dispersed, then add chlorhexidine acetate (0.05% addition) and onion juice in sequence, and continue stirring for 16 minutes to ensure uniform mixing and eliminate air bubbles.

[0037] (5) The obtained gel ointment is divided into aluminum tubes, and random samples are taken for stability test (45°C, -15°C cycle test for 30 days). No delamination, discoloration, odor, texture, or spreadability is observed, and all meet the requirements.

[0038] Embodiment 5 The present embodiment provides a preparation method of a gel ointment for relieving or treating functional constipation, which comprises the following steps: (1) Preparation of Chinese medicine extract and onion juice: Baishao, Chenpi, Shengdi, Danggui, Gancao, and Xingren were combined and soaked in 5 times the amount of cold water for 60 minutes. They were decocted three times: 1.5 hours for the first time, 1 hour for the second time, and 0.5 hours for the third time. The decocted liquids were combined, filtered, and the filtrate was concentrated to a relative density of 1.10 (60°C) to obtain the extract. Onion was chopped and squeezed to obtain onion juice.

[0039] (2) Under stirring (70 r / min), Carbopol 940 (0.3% addition) was slowly added to the aloe concentrated juice. After the addition was completed, the stirring speed was increased to 150 r / min, and stirring was continued for 40 minutes until the system was a uniform viscous liquid without visible particles, obtaining a preliminary gel.

[0040] (3) The stirring was maintained, and NaOH solution (1:4) was slowly added dropwise to the preliminary gel. The pH value of the system was adjusted to 5.5 by monitoring with a precision pH meter during the process. Stirring was continued for 22 minutes until a transparent and uniform gel was formed.

[0041] (4) The stirring speed was reduced to 80 r / min, and the Chinese medicine extract prepared in step (1) was added. After stirring for 20 minutes to ensure uniform dispersion, chlorhexidine acetate (0.01% addition) and onion juice were added in sequence, and stirring was continued for 15 minutes to ensure uniform mixing and eliminate air bubbles.

[0042] (5) The obtained gel ointment was divided into aluminum tubes, and random samples were taken for stability testing (45°C, -15°C cycle test for 30 days). No delamination, discoloration, odor, texture, or spreadability was observed, and the results met the requirements.

[0043] Example 6 The present example provides a preparation method of a gel ointment for relieving or treating functional constipation, which includes the following steps: (1) Preparation of Chinese medicine extract and onion juice: Baishao, Chenpi, Shengdi, Danggui, Gancao, and Xingren were combined and soaked in 5 times the amount of cold water for 30 minutes. They were decocted three times: 1.5 hours for the first time, 1 hour for the second time, and 0.5 hours for the third time. The decocted liquids were combined, filtered, and the filtrate was concentrated to a relative density of 1.10 (60°C) to obtain the extract. Onion was chopped and squeezed to obtain onion juice.

[0044] (2) Under stirring (70 r / min), Carbopol 940 (0.8% addition) was slowly added to the aloe concentrated juice. After the addition was completed, the stirring speed was increased to 200 r / min, and stirring was continued for 30 minutes until the system was a uniform viscous liquid without visible particles, obtaining a preliminary gel.

[0045] (3) While stirring, slowly add NaOH solution (1:4) to the initial gel, and monitor the pH with a precision pH meter during the process. Adjust the pH of the system to 6.5. Continue stirring for 20 minutes until a transparent and homogeneous gel is formed.

[0046] (4) Reduce the stirring speed to 60 r / min, add the Chinese herbal extract prepared in step (1), stir for 20 minutes to disperse it evenly, then add chlorhexidine acetate (0.02%) and onion juice in sequence, and continue stirring for 15 minutes to ensure even mixing and eliminate air bubbles.

[0047] (5) The obtained gel ointment was packaged into aluminum tubes and random samples were taken for stability testing (45℃, -15℃ cycle test for 30 days). No layering, discoloration or odor was observed. The texture and spreadability met the requirements.

[0048] Examples 4-6 show the finished gel ointment products. Figure 1 From left to right, the images show the finished gel ointments corresponding to Examples 4, 5, and 6, with their colors exhibiting a gradient of decreasing hue. This color gradient is a direct result of the differences in raw material ratios, particularly the content of key components such as concentrated aloe vera juice, and the effects of decoction and concentration process parameters in the different examples. It visually reflects the correlation between the product's internal components and physical properties, demonstrating the controllability of the process and the adjustability of the product in this invention.

[0049] When using this gel ointment, take an appropriate amount as a massage medium and apply it to the corresponding acupoints. A professional physician should then apply standard pediatric constipation massage techniques. In vitro transdermal absorption tests and pre-clinical trials have confirmed that this product effectively promotes transdermal drug absorption, significantly improves the frequency of spontaneous bowel movements per week, stool form, and the degree of difficulty in defecation in children. Furthermore, skin allergy tests show no irritation or allergic reactions, indicating high safety.

[0050] Comparative Example 1 The difference from Example 4 is that it does not contain aloe vera concentrate. Instead, water is used to replace aloe vera concentrate. The extract was prepared using the same method and an attempt was made to make the paste. It was found that the compatibility with the gel matrix was poor and the dispersion of the active ingredients was not uniform.

[0051] Comparative Example 2 The difference from Example 4 is that a conventional aqueous matrix, such as sodium carboxymethyl cellulose, is used instead of a carbomer gel matrix. The resulting paste has excessive adhesion, poor air permeability, and is prone to dehydration and drying after long-term storage.

[0052] Comparative Example 3 The comparative example provides a traditional Chinese medicine composition and its gel ointment for relieving or treating functional constipation in children, which is prepared from the following raw materials by weight: Radix Paeoniae Alba 55.95 parts, Pericarpium Citri Reticulatae 37.3 parts, Radix Rehmanniae 37.3 parts, Angelica sinensis 37.3 parts, and Glycyrrhiza 18.65 parts.

[0053] The gel ointment is prepared as follows: (1) Preparation of traditional Chinese medicine extract and onion juice: Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Radix Rehmanniae, Angelica sinensis, and Glycyrrhiza are combined and soaked in 10 times the amount of cold water for 45 minutes, and then decocted for three times: 1.5 hours for the first time, 1 hour for the second time, and 0.5 hours for the third time. The three decoction liquids are combined, filtered, and concentrated to a relative density of 1.15 (60°C) to obtain the extract.

[0054] (2) Under stirring (speed 70 r / min), carbomer 940 (addition amount 0.5%) is slowly added to water, and the feeding time is about 12 minutes. After feeding, the stirring speed is increased to 180 r / min, and stirring is continued for 35 minutes until the system is a uniform viscous liquid without visible particles, and an initial gel is obtained.

[0055] (3) Keep stirring, and slowly add NaOH solution (1:4) to the initial gel, and monitor the pH value with a precision pH meter during the process to adjust the pH value of the system to 6.0. Continue stirring for 22 minutes until a transparent and uniform gel is formed.

[0056] (4) Reduce the stirring speed to 70 r / min, add the traditional Chinese medicine extract prepared in step (1), and stir for 18 minutes to make it uniformly dispersed, then add chlorhexidine acetate (addition amount 0.05%) and onion juice in sequence, and continue stirring for 16 minutes to ensure uniform mixing and eliminate air bubbles.

[0057] Example 1 of effect test 1. Selection of subjects and grouping 1.1 Diagnostic criteria: The enrollment of constipated children must strictly comply with the diagnostic criteria for functional constipation in children in the Rome IV criteria, which are as follows (applicable to children who have received toilet training): ① Defecation ≤2 times per week in public places; ② At least 1 episode of fecal incontinence per week; ③ History of excessive restraint of defecation or posture; ④ History of defecation pain or difficulty; ⑤ Presence of large fecal mass in the rectum; ⑥ History of passing large feces, which may even cause toilet blockage. (Note: At least 2 or more of the above conditions must be met before diagnosis, and the symptoms must last for at least 1 month.) 1.2 Sample size and grouping: 90 subjects aged 4-12 years are planned to be recruited and divided into three groups: Group A: Healthy control group (n=30): Healthy children with normal defecation, aiming to establish baseline data of children's defecation in the region.

[0058] Group B: Control group 3 (n=30): Children with functional constipation meeting the Rome IV diagnostic criteria.

[0059] Group C: Example group 4 (n=30): Children with functional constipation meeting the Rome IV diagnostic criteria.

[0060] Note: The recruitment of all subjects requires the signature of the informed consent form by their guardians, and the research protocol will be reviewed by the ethics committee.

[0061] 2. Test method 2.1 Intervention plan: Group A (healthy control group): No intervention measures are taken, and only the guardian is required to complete the 2-week "Children's Defecation Diary Card".

[0062] Group B (control group 3): Use control group 3 as the medium for massage, and perform standard pediatric constipation massage techniques by a fixed qualified massage physician. Treatment is performed 3 times a week, and the course lasts for 2 weeks.

[0063] Group C (example group 4): Use example group 4 as the medium for massage, and the massage technique, treatment frequency, and course are exactly the same as group B.

[0064] 2.2 Observation period and indicators: The study lasts for 2 weeks. All constipated children (groups B and C) need to record the "Children's Defecation Diary Card" in detail by the guardian from 1 week before treatment to 1 week after treatment.

[0065] 3. Efficacy evaluation criteria (core indicator table) The following five core efficacy indicators are evaluated by the attending physician before and after treatment based on the diary card records: ① Weekly spontaneous bowel movement frequency (SBM) is not assisted by Kaiselu, enema, etc. The number of bowel movements completed by the child.

[0066] ② Weekly completely spontaneous bowel movement frequency (CSBM) is the number of bowel movements completed by the child, and the abdominal fullness disappears after defecation, feeling "clean".

[0067] ③ Stool form (BSFS) is evaluated using the Bristol Stool Form Scale (1-7 type), and the most typical form is recorded each week.

[0068] Using the Bristol Stool Form Scale (BSFS): Type 1: Dispersed hard lumps, like nuts, not easy to expel.

[0069] Type 2: Sausage-like, but the surface is uneven.

[0070] Type 3: Sausage shape, but with surface cracks.

[0071] Type 4: Sausage or snake shape, smooth surface.

[0072] Type 5: Soft mass shape, clear edge.

[0073] Type 6: Fluff, unclear edge, paste stool.

[0074] Type 7: Watery stool, no solid components.

[0075] (4) Difficulty of defecation (VAS) : Visual analogue scale (0-10) was used, and the guardian scored according to the child's performance.

[0076] The Rome IV standard behavior indicators were used: This standard is defined by the following objective behavior indicators: a. Struggle / cry during defecation: The child struggles very hard, turns red, or cries because of the struggle during defecation.

[0077] b. Prolonged defecation time: The duration of a single defecation is more than 10-15 minutes.

[0078] c. Defecation pain: The child complains or shows pain during defecation.

[0079] d. Defecation restraint posture: The child shows typical restraint defecation postures such as standing on tiptoe, tensing the legs, hiding behind furniture, etc.

[0080] (5) Number of times of using Kaiselu / laxatives: The number of times of using Kaiselu or other laxatives for auxiliary defecation per week was recorded.

[0081] 4. Data statistics and analysis: All data will be processed by SPSS 27.0 software. The measurement data will be represented by mean ± standard deviation (x̄ ± SD), and the paired sample t-test will be used for comparison before and after treatment within the group, and the single factor analysis of variance will be used for comparison between groups. P<0.05 is considered statistically significant.

[0082] Experimental results 1. Comparison of the number of spontaneous defecation per week (SBM) The results in Table 1 show that the number of spontaneous defecation per week in the C group after treatment reached 5.8 times, which was significantly higher than that in the B group (3.5 times), indicating that the Example 4 group had more advantages in restoring the intestinal self-defecation function.

[0083] Table 1 Comparison results of the number of spontaneous defecation per week (SBM) in the effect test Example 1

[0084] 2. Comparison of the number of completely spontaneous bowel movements (CSBM) per week The results are shown in Table 2. The results show that the number of completely spontaneous bowel movements of the C group is increased to 4.2 times, which is much higher than the 1.9 times of the B group, proving that the effect of the example 4 group in promoting complete defecation is more significant.

[0085] Table 2 Comparison of the number of completely spontaneous bowel movements (CSBM) per week in the effect test example 1

[0086] The comparison results of the stool form (BSFS) are shown in Table 3. The results show that the stool form score of the C group is 4.0, which is significantly better than the 2.8 of the B group, indicating that the example 4 group can more effectively improve the stool properties.

[0087] Table 3 Comparison of the stool form (BSFS) in the effect test example 1

[0088] 4. Comparison of the degree of difficulty in defecation (VAS) The results are shown in Table 4. The results show that the degree of difficulty in defecation of the C group is reduced to 1.8, which is significantly lower than the 4.5 of the B group, indicating that the effect of the example 4 group in relieving the pain of defecation is more prominent.

[0089] Table 4 Comparison of the degree of difficulty in defecation (VAS) in the effect test example 1

[0090] 5. Comparison analysis of the number of uses of Glycerol The results are shown in Table 5. The results show that the number of uses of Glycerol of the C group is reduced to 0.3 times, which is much lower than the 1.5 times of the B group, proving that the example 4 group can more effectively help patients get rid of drug dependence.

[0091] Table 5 Comparison analysis results of the number of uses of Glycerol in the effect test example 1

[0092] The degree of dependence on Glycerol is an important indicator for judging whether constipation is cured. The results prove that the drugs of the example 4 group can restore the natural defecation ability of most patients and no longer need external strong stimulation. This proves from the perspective of "reducing drug dependence" that the present application has the potential to replace existing stimulant therapy and higher safety.

[0093] It should be pointed out finally that the above embodiments are only used to illustrate the technical solutions of the present application, but not to limit the same; and although the present application has been described in detail with reference to the foregoing embodiments, it should be appreciated by those skilled in the art that the technical solutions recorded in the foregoing embodiments can be modified, or some technical features thereof can be replaced equivalently; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A traditional Chinese medicine composition for relieving or treating functional constipation, characterized in that, It is made from the following ingredients in parts by weight: 50-56 parts white peony root, 20-40 parts dried tangerine peel, 30-37 parts raw rehmannia root, 30-41 parts angelica root, 15-19 parts licorice root, 3-6 parts almond, 10-12 parts scallion, and 50-70 parts concentrated aloe vera juice.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The aloe vera concentrate is a concentrated extract of Aloe vera leaf juice with a purity of ≥99%.

3. A gel-cream for relieving or treating functional constipation, characterized in that, It comprises the traditional Chinese medicine composition as described in claim 1 or 2, and pharmaceutically acceptable excipients.

4. The formulation according to claim 3, characterized in that, Pharmaceutically acceptable excipients include gel matrix, preservatives, and pH adjusters.

5. The formulation according to claim 4, characterized in that, The gel matrix is ​​carbomer, the preservative is chlorhexidine acetate, and the pH adjuster is NaOH.

6. The formulation according to claim 4, characterized in that, The amount of carbomer used is 0.3% to 0.8% based on the total weight of the gel ointment; the amount of chlorhexidine acetate used is 0.01% to 0.05%.

7. A method for preparing a gel-cream as described in any one of claims 3-6, characterized in that, Includes the following steps: (1) Preparation of Chinese herbal extract and onion juice: Weigh out white peony root, tangerine peel, raw rehmannia root, angelica root, licorice root and apricot kernel according to the proportion, combine them and extract with water, concentrate the extract to obtain Chinese herbal extract, and separately take chopped scallion whites and squeeze out the juice to obtain onion juice; (2) Disperse the gel matrix in aloe vera concentrate and allow it to swell to form a primary gel; (3) Add NaOH solution to the initial gel obtained in step (2), adjust the pH to 5.5-6.5, and stir to make it completely gelled; (4) Add the Chinese herbal extract obtained in step (1) to the gel obtained in step (3) and stir until evenly mixed. Then add the preservative and onion juice and stir until evenly mixed to obtain the final product.

8. The method according to claim 7, characterized in that, In step 1, the mass-volume ratio of water to medicinal materials is 1:5-10, with units of g / ml; the extraction method is to first soak for 30-60 minutes, then decoct three times, the first decoction for 1.5 hours, the second decoction for 1 hour, and the third decoction for 0.5 hours, and then combine the decoctions, filter and concentrate.

9. The method according to claim 11, characterized in that, The gel matrix in step (2) is Carbomer 940; the swelling is performed by swelling for 30 to 40 minutes at a stirring speed of 150 to 200 r / min; the NaOH solution in step (3) is a solution with a NaOH to water ratio of 1:

4.

10. The method according to claim 11, characterized in that, In step (4), the stirring is performed at a stirring speed of 60-80 r / min for 15-20 minutes.

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